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510(k) Data Aggregation

    K Number
    K012419
    Device Name
    CONFORM SHEETING, MODEL IGEL
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    2001-10-24

    (86 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONFORM SHEETING, MODEL IGEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called "Conform Sheeting, Model IGEL." It is a regulatory document addressing the substantial equivalence of the device to legally marketed predicate devices.

    This document DOES NOT contain information about acceptance criteria, device performance specifications, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

    The letter is focused on the regulatory approval process and states that the device is substantially equivalent for its intended use, which is in the management and prevention of keloid and hypertrophic scars. It does not provide any technical performance data or a study description of the kind requested.

    Therefore, I cannot fulfill the request using only the provided text.

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